Monday, March 23, 2020 10:15 AM
COMPANY’S EMERGENCY USE (EUA) APPLICATION TO BE UPDATED IN THE NEXT WEEK AS MANUFACTURING SPECIFICATIONS FINALIZED, DISCUSSION OF GENVIRO! UNIQUE QUALITIES ENSUES
LOS ANGELES, CA / ACCESSWIRE / March 23, 2020 /Decision Diagnostics Corp. (OTC PINK:DECN) is an 18-year old, diabetes-focused bio-technology development firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! (“Sunshine”) diabetes test strip, its GenAccord! Enhance (“Caterpillar”) strip and meter systems for the uninsured and under-insured, its GenChoice! (“Ladybug”) test strip now in the later stages of FDA 510(k) prosecution, and its GenUltimate! Precis products manufactured for International markets, and its GenViro! Rapid Kits for the real time testing for the Coronavirus (COVID-19) now seeking FDA Emergency Waiver (EUA).
Today, DECN announces that the company, through its advanced development team in Korea, have finalized the configuration of the GenViro! Swift Kit test strip that will go into production just as soon as the FDA grants emergency status to the DECN product. The company’s methodology employs a simple, easy to use, swift (15 seconds and faster than Rapid) method for determining the presence of a virus in blood lyced into blood plasma. Blood sample requirements are 1-2 microliters. The kits will be manufactured for DECN in Korea by its contract manufacturer, the same company that manufactures our diabetic test strips. While the manufacturing will occur in Korea, the test strip is 100% of American design.